Trial Outcomes & Findings for Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart (NCT NCT01961323)

Results Overview

measured by stress echocardiogram, number of participants who had improvement in METS and improvement in exercise time as compared to their baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

at 6 months

Results posted on

2017-11-24

Participant Flow

Recruitment took place at Icahn School of Medicine at Mount Sinai outpatient cardiology clinic from Dec 11, 2014 to Dec 2, 2016.

Participant milestones

Participant milestones
Measure	Nebivolol Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Overall Study STARTED	70
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Nebivolol Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	8
Overall Study screen failure	34

Baseline Characteristics

Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=36 Participants Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Age, Continuous	50.3 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Body Mass Index (BMI)	31 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants
B-type Natriuretic Peptide (BNP) Blood Test	19.8 pg/mL STANDARD_DEVIATION 13 • n=5 Participants
Resting Heart Rate	74.5 beat/minute STANDARD_DEVIATION 14 • n=5 Participants
Systolic Blood Pressure (SBP)	142 mmHG STANDARD_DEVIATION 16.6 • n=5 Participants
Diastolic Blood Pressure (DBP)	92.9 mmHG STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: at 6 months

Population: Study results only for those who completed the study

measured by stress echocardiogram, number of participants who had improvement in METS and improvement in exercise time as compared to their baseline.

Outcome measures

Outcome measures
Measure	Nebivolol n=21 Participants Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Improvement in Exercise Tolerance Improvement in METs and exercise time	9 Participants
Improvement in Exercise Tolerance Improvement in exercise time only	8 Participants

SECONDARY outcome

Timeframe: at 6 months

Population: Results for the participants who had improved exercise capacity only (from Outcome Measure 1)

measured as a part of stress echocardiogram, E/e' ratio: The normal E/e' ratio from the medial annulus is \<8 and suggests a normal left atrial pressure. While values between 8 and 12 are indeterminate, a value \>12 is indicative of an elevated left atrial pressure or PCWP (\>18mmHg). The ranges for E/e' from the lateral mitral annulus are \<5, 5 -10 and \>10 respectively.

Outcome measures

Outcome measures
Measure	Nebivolol n=17 Participants Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
E Velocity Indexed to e' (E/e' Ratio) of the Left Ventricle Resting	7.5 ratio Standard Deviation 5.2
E Velocity Indexed to e' (E/e' Ratio) of the Left Ventricle Peak Exercise	8.8 ratio Standard Deviation 1.6

SECONDARY outcome

Timeframe: at 6 months

measured as a part of stress echocardiogram, number of participants with significant improvement in the LV untwist after Nebivolol treatment in patients who completed the study

Outcome measures

Outcome measures
Measure	Nebivolol n=21 Participants Nebivolol 5 mg (titrated to a maximal dose of 10mg for optimal blood pressure) for 6 months Nebivolol: Doses titrated based on weekly visits during the first 2 weeks to achieve a target SBP\<140 and DBP \<90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
Untwist Rate of the Left Ventricle	0 Participants

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Partho Sengupta

Icahn School of Medicine at Mount Sinai

Phone: 212-659-8847

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place