Trial Outcomes & Findings for Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains (NCT NCT02263729)

Last Updated: 2024-05-02

Results Overview

Directly related to specific aim 1- Side effects, safety, and tolerability will be monitored by measuring vital signs, lab values via blood work, and number of adverse events, serious adverse events, and patient reported side effects.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-05-02

Participant Flow

Participants were referred to the study by their athletic trainer and/or physician at the UPMC Center for Sports Medicine/ University of Pittsburgh between July 2016 and December 2022. The first participant was enrolled on August 10, 2016, and the last participant was enrolled on August 4, 2021.

Of the 183 individuals with hamstring injuries screened for the study, 17 met the inclusion/exclusion criteria and were eligible for the study. Nine of the eligible individuals declined to consent, and 8 agreed to consent. Two participants withdrew from the study prior to randomization, leaving 6 participants randomized to treatment.

Participant milestones

Participant milestones
Measure	Losartan Subjects took 50mg of Losartan per day for 4 weeks.	Placebo Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Overall Study STARTED	3	3
Overall Study Week 1 Follow-up	3	3
Overall Study Week 2 Follow-up	3	3
Overall Study Week 3 Follow-up	3	3
Overall Study Week 4 Follow-up	3	3
Overall Study Week 6 Follow-up	2	3
Overall Study 3 Month Follow-up	2	3
Overall Study 6 Month Follow-up	2	3
Overall Study 9 Month Follow-up	2	3
Overall Study 12 Month Follow-up	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Losartan Subjects took 50mg of Losartan per day for 4 weeks.	Placebo Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.	Total n=6 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	21.7 years n=7 Participants	26.8 years n=5 Participants
Age, Customized Age · 21 years old	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Age · 22 years old	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Age · 28 years old	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized Age · 47 years old	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Body Mass Index	28.5 kg/m^2 STANDARD_DEVIATION 3.0 • n=5 Participants	28.6 kg/m^2 STANDARD_DEVIATION 4.2 • n=7 Participants	28.5 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
Side of Injury Left	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Side of Injury Right	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Primary Sport Baseball	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Primary Sport Football	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Primary Sport Soccer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Primary Sport Tennis	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Extent of the initial injury: Proximal-distal length	23.0 centimeters n=5 Participants	21.8 centimeters n=7 Participants	22.4 centimeters n=5 Participants
Extent of the initial injury: Volume of injury	588.4 cubic centimeters n=5 Participants	816.8 cubic centimeters n=7 Participants	702.6 cubic centimeters n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability Abnormal labs	0 Participants	0 Participants
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability Hypotension	0 Participants	0 Participants
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability Serious adverse events	0 Participants	0 Participants
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability Drug related adverse event	0 Participants	0 Participants
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability Side effects	0 Participants	0 Participants
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability No adverse events, serious adverse events, and patient reported side effects.	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 6 weeks; 6 months

Population: Losartan Group: 4 wk data at 30 \& 90 degrees substituted for 6 wk data (1 subject lost to follow-up at 4 wks, 1 data not collected). 6 wk data at 60 degrees missing for subject lost to follow-up at 4 wks. 6 m data missing for subject lost to follow-up at 4 wks \& not collected for 1 subject Placebo group: 6 wk data at 60 degrees not collected for 1 participant. 6 m data missing for 1 subject that moved out of the area prior to 6 m \& data not collected for 1 subject at 60 degrees of flexion

For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 30, 60, and 90 degrees of knee flexion at 6 weeks and 6 months. Data are expressed as a Limb Symmetry Index (LSI), which is the percent force of the injured hamstring compared to the force of the non-injured hamstring muscle.

Outcome measures

Outcome measures
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function 6 weeks: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	91 % of contralateral limb strength Interval 42.0 to 139.0	75 % of contralateral limb strength Interval 21.0 to 129.0
Recovery of Hamstring Muscle Function 6 weeks: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	102 % of contralateral limb strength Interval 67.0 to 137.0	77 % of contralateral limb strength Interval 69.0 to 85.0
Recovery of Hamstring Muscle Function 6 weeks: Limb Symmetry Index isometric strength at 60 deg knee flexion (Biodex)	79 % of contralateral limb strength Interval 59.0 to 98.0	73 % of contralateral limb strength Interval 15.0 to 130.0
Recovery of Hamstring Muscle Function 6 months: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	107 % of contralateral limb strength Interval 0.0 to 323.0	95 % of contralateral limb strength Interval 0.0 to 355.0
Recovery of Hamstring Muscle Function 6 months: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	106 % of contralateral limb strength Interval 0.0 to 290.0	76 % of contralateral limb strength Interval 0.0 to 590.0
Recovery of Hamstring Muscle Function 6 months: Limb Symmetry Index isometric strength at 60 deg knee flexion (%, Biodex)	83 % of contralateral limb strength Interval 45.0 to 121.0	104 % of contralateral limb strength

PRIMARY outcome

Timeframe: 6 months

Population: Losartan group: one participant was completely lost to follow-up after 4 weeks. There is also missing MRI data for 6-month timepoint for one other participant. Placebo group: one participant moved out of the area before the 6-month visit and did not complete the 6 month clinical research visit.

For specific aim 2, recovery of hamstring structure was measured as the length of injury at 6 months as well as the change in proximal-distal length of injury from baseline to 6 month post-treatment MRI. Greater change in length represents greater healing.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=2 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Structure Proximal-distal length of injury measured (MRI)	0.8 centimeters	5.6 centimeters Interval 0.0 to 67.0
Recovery of Hamstring Structure Change in proximal-distal length of injury from baseline (MRI)	23 centimeters	17.6 centimeters Interval 0.0 to 140.0

PRIMARY outcome

Timeframe: 6 months

For specific aim 2, hamstring structure was measured in terms of the volume of fibrosis at 6 month MRI, as such smaller volume of fibrosis represents greater healing of the hamstring muscle. Hamstring structure was also determined by comparing the change of pre-treatment volume of the injury on the baseline MRI to the volume of fibrosis on the 6 month MRI.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=2 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Structure Change of pre-treatment volume of the injury to 6 months (MRI)	138.4 cubic centimeters	1028 cubic centimeters Interval 0.0 to 10691.0
Recovery of Hamstring Structure Volume of fibrosis at 6 months (MRI)	0.6 cubic centimeters	0.7 cubic centimeters Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 12 months

Population: Despite losing one participant in the Losartan group after 4 weeks and one in the placebo group after 9 months, data for this outcome was able to be collected and analyzed as the participants returned to their prior level of function before they were lost to follow-up.

Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice. This could have occurred at any timepoint after 6 weeks, so this did not necessarily occur at 12 months but it was monitored until the 12 month timepoint.

Outcome measures

Outcome measures
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Return to Prior Level of Function	23 days Interval 14.0 to 42.0	35 days Interval 7.0 to 70.0

PRIMARY outcome

Timeframe: 12 months

Population: Losartan group: one participant was completely lost to follow-up after 4 weeks. Placebo group: one participant moved out of the area before the 6-month visit and did not complete the clinical assessment portion, however reinjury reporting was tracked until 9 months, after which the individual was lost to further follow-up.

Number of recurrent injuries will be monitored during the duration of the subjects participation.

Outcome measures

Outcome measures
Measure	Losartan n=2 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recurrence of Injury Recurrent hamstring injury	0 Participants	2 Participants
Recurrence of Injury No recurrent hamstring injury	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

For specific aim 2, restoration of hamstring structure was operationally defined as the ratio of the volume of the injured to contralateral leg hamstring volume 6 months after injury 6 months post-injury. The percent of hamstring volume of the injured leg was expressed as a percentage of the hamstring volume of the contralateral normal leg. The difference in volume between the involved and non-involved hamstring muscles was divided by the non-involved hamstring muscle volume and multiplied by 100.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=2 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Structure	0.91 Percent of contralateral hamstring vol	3.9 Percent of contralateral hamstring vol Interval -2.8 to 10.7

SECONDARY outcome

Timeframe: 4 Weeks, 6 Weeks, 3 Months, 4 Months, 6 Months, 12 Months

Population: Losartan group: one participant was completely lost to follow-up after 4 weeks. Placebo group: one participant moved out of the area before the 6-month visit and did not complete the clinical assessment portion of the research follow-up, then was completely lost to follow-up after the 9 month telephone call.

For specific aims 3 and 4, return to prior level of sports activity was measured by the Marx Activity Scale Score, which ranges from 0 to 16, with 16 being the highest level of sports activity. The frequency of participants who achieved the same or better Marx score at follow-up compared to baseline was calculated. Differences from baseline to each follow-up timepoint were calculated by subtracting the follow-up scores from baseline. Any difference of 0 or a negative number indicated the participants achieved the same level of sports activity or better. Positive differences indicated they did not return to their prior level of sports activity.

Outcome measures

Outcome measures
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 4 Weeks	1 Participants	1 Participants
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 6 Weeks	1 Participants	1 Participants
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 3 Months	2 Participants	3 Participants
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 4 Months	1 Participants	3 Participants
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 6 Months	1 Participants	1 Participants
Return to Prior Level of Function Marx Activity Level Score: Achieved prior level or better at 12 Months	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 weeks; 6 months

Population: Losartan group: one participant was completely lost to follow-up after 4 weeks. Placebo group: one participant moved out of the area before the 6-month visit and did not complete the clinical research follow-up and then was completely lost to follow-up after the 9 month telephone call.

For specific aim 2, hamstring muscle flexibility of the injured leg was measured and compared to the contralateral leg using the popliteal angle at 6 weeks and 6 months after randomization. The popliteal angle was measured with a goniometer. Recovery of hamstring flexibility was operationally defined as the difference in the popliteal angle between the contralateral normal leg minus the hamstring injured leg. Positive differences between the contralateral and injured leg indicated decreased hamstring flexibility.

Outcome measures

Outcome measures
Measure	Losartan n=2 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Flexibility Difference in popliteal angle between injured and non-injured limb at 6 weeks	1.0 difference in degrees of popliteal angle Interval -11.7 to 13.7	-1.3 difference in degrees of popliteal angle Interval -7.1 to 4.4
Recovery of Hamstring Flexibility Difference in popliteal angle between injured and non-injured limb at 6 months	-1.5 difference in degrees of popliteal angle Interval -20.6 to 17.6	-0.5 difference in degrees of popliteal angle Interval -6.9 to 5.9

SECONDARY outcome

Timeframe: 1 week; 2 weeks; 3 week; 4 weeks

Population: For the 4 week strength assessment, one participant in the Losartan group did not have isometric strength testing completed.

For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 1 week, 2 weeks, 3 weeks, and 4 weeks. Data were expressed as a Limb Symmetry Index (LSI), which is the percent strength of the injured hamstring in comparison to the strength of the non-injured hamstring muscle.

Outcome measures

Outcome measures
Measure	Losartan n=3 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function 1 week: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	70.8 % of contralateral limb strength Interval 0.3 to 141.2	54.9 % of contralateral limb strength Interval -37.2 to 147.1
Recovery of Hamstring Muscle Function 1 week: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	83.9 % of contralateral limb strength Interval 62.2 to 105.6	39.8 % of contralateral limb strength Interval -59.7 to 139.2
Recovery of Hamstring Muscle Function 2 weeks: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	83.3 % of contralateral limb strength Interval 39.8 to 126.8	50.1 % of contralateral limb strength Interval 28.8 to 71.4
Recovery of Hamstring Muscle Function 2 weeks: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	93.8 % of contralateral limb strength Interval 60.1 to 127.5	44.6 % of contralateral limb strength Interval 23.1 to 66.2
Recovery of Hamstring Muscle Function 3 weeks: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	103.0 % of contralateral limb strength Interval -24.1 to 230.2	87.2 % of contralateral limb strength Interval 47.9 to 126.4
Recovery of Hamstring Muscle Function 3 weeks: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	95.9 % of contralateral limb strength Interval -0.7 to 192.5	69.1 % of contralateral limb strength Interval -1.3 to 139.4
Recovery of Hamstring Muscle Function 4 weeks: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	79.1 % of contralateral limb strength Interval 45.6 to 112.7	82.5 % of contralateral limb strength Interval 44.2 to 120.7
Recovery of Hamstring Muscle Function 4 weeks: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	106.5 % of contralateral limb strength Interval -35.3 to 248.3	91.6 % of contralateral limb strength Interval 69.0 to 114.1

SECONDARY outcome

Timeframe: 6 weeks, 6 months

Population: Losartan group: At 6 weeks, one participant was completely lost to follow-up after 4 weeks, and another participant did not complete isokinetic testing. At 6 months, data was collected for one participant, since one was lost to follow-up and the other did not complete isokinetic testing. Placebo group: At 6 weeks, data is missing for one participant, and another did not complete isokinetic testing. At 6 months, data was not collected for this group.

For specific aim 2, hamstring muscle function of the injured leg was measured on the Biodex and compared to the contralateral leg using isokinetic peak torque at 60 degrees and 180 degrees per second at 6 weeks and 6 months. Data were expressed as a Limb Symmetry Index (LSI), which is the percent peak torque of the injured hamstring compared to the peak torque of the non-injured hamstring muscle. The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=1 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function 6 Weeks: Limb Symmetry Index isokinetic peak torque at 60 deg per second (Biodex)	96.5 % of contralateral limb peak torque	202.7 % of contralateral limb peak torque
Recovery of Hamstring Muscle Function 6 Weeks: Limb Symmetry Index isokinetic peak torque at 180 deg per second (Biodex)	104.1 % of contralateral limb peak torque	71.2 % of contralateral limb peak torque
Recovery of Hamstring Muscle Function 6 Months: Limb Symmetry Index isokinetic peak torque at 60 deg per second (Biodex)	105.3 % of contralateral limb peak torque	—
Recovery of Hamstring Muscle Function 6 Months: Limb Symmetry Index isokinetic peak torque at 180 deg per second (Biodex)	81.3 % of contralateral limb peak torque	—

SECONDARY outcome

Timeframe: 6 weeks, 6 months

For specific aim 2, hamstring muscle function of the injured leg was measured on the Biodex and compared to the contralateral leg using isokinetic total hamstring work at 60 degrees per second and 180 degrees per second at 6 weeks and 6 months. Data were expressed as a Limb Symmetry Index (LSI), which is the percent total work of the injured hamstring compared to the total work of the non-injured hamstring muscle. The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=1 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function 6 Weeks: Limb Symmetry Index isokinetic total hamstring work at 60 deg per second (Biodex)	108.9 % of contralateral limb total work	484.2 % of contralateral limb total work
Recovery of Hamstring Muscle Function 6 Weeks: Limb Symmetry Index isokinetic total hamstring work at 180 deg per second (Biodex)	134.2 % of contralateral limb total work	63.3 % of contralateral limb total work
Recovery of Hamstring Muscle Function 6 Months: Limb Symmetry Index isokinetic total hamstring work at 60 deg per second (Biodex)	113.8 % of contralateral limb total work	—
Recovery of Hamstring Muscle Function 6 Months: Limb Symmetry Index isokinetic total hamstring work at 180 deg per second (Biodex)	78.9 % of contralateral limb total work	—

SECONDARY outcome

Timeframe: 6 weeks, 6 months

For specific aim 2, the ratio of hamstring peak torque to quadriceps peak torque at 60 degrees per second of the injured and non-injured legs were measured on the Biodex at 6 weeks. The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=1 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function 6 Weeks: Ratio of hamstring peak torque to quadriceps peak torque at 60 deg per second	51.9 ratio of hams. to quad. peak torque	33.9 ratio of hams. to quad. peak torque
Recovery of Hamstring Muscle Function 6 Months: Ratio of hamstring peak torque to quadriceps peak torque at 60 deg per second	70.7 ratio of hams. to quad. peak torque	—

SECONDARY outcome

Timeframe: 6 weeks, 6 months

Population: Losartan group: At 6 weeks, one participant was completely lost to follow-up after 4 weeks, and another participant did not complete isokinetic testing. Placebo group: At 6 weeks, data is missing for one participant, and another did not complete isokinetic testing. Data was not collected at 6 months for either group.

For specific aim 2, the ratio of hamstring work in the last 3 repetitions to work in the first 3 repetitions at 180 degrees per second of the injured leg was measured on the Biodex at 6 weeks. The isokinetic testing was not consistently collected, so there are no results to present at 6 months.

Outcome measures

Outcome measures
Measure	Losartan n=1 Participants Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=1 Participants Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Recovery of Hamstring Muscle Function	153.1 ratio of work in last 3 to first 3 reps	76.7 ratio of work in last 3 to first 3 reps

Adverse Events

Losartan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Losartan n=3 participants at risk Subjects took 50mg of Losartan per day for 4 weeks.	Placebo n=3 participants at risk Subjects were given a placebo to replicate the appearance of Losartan pills. Placebo pill was taken once per day.
Musculoskeletal and connective tissue disorders Hamstring reinjury	0.00% 0/3 • 12 months During the 4 week period of active intervention while taking the Losartan or placebo, subjects were followed weekly with activity level and adverse event monitoring and blood pressure measurements. Activity level and adverse event monitoring also occurred via telephone follow-up at 12 weeks and 4, 9, and 12 months. Blood pressure was also evaluated at 6 weeks and 6 months. Blood work (and pregnancy tests for women) was assessed at 2, 4, and 6 weeks after randomization.	66.7% 2/3 • Number of events 2 • 12 months During the 4 week period of active intervention while taking the Losartan or placebo, subjects were followed weekly with activity level and adverse event monitoring and blood pressure measurements. Activity level and adverse event monitoring also occurred via telephone follow-up at 12 weeks and 4, 9, and 12 months. Blood pressure was also evaluated at 6 weeks and 6 months. Blood work (and pregnancy tests for women) was assessed at 2, 4, and 6 weeks after randomization.

Additional Information

James J. Irrgang

University of Pittsburgh

Phone: 412-383-9865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place