Trial Outcomes & Findings for Acupuncture on Cardiac and Autonomic Function in Human Heart Failure (NCT NCT01804816)

NCT ID: NCT01804816

Last Updated: 2025-11-04

Results Overview

Left ventricular ejection fraction (LVEF) percentage was measured at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline, Week 7, Week 13
• Results posted on: 2025-11-04

Participant Flow

Participants were recruited from the Cleveland Clinic Heart and Vascular Institute section of Heart Failure and Transplant Medicine.

All subjects acted as their own controls for this study and were assigned to a 5 week period of no acupuncture or other study interventions (control) followed by a 5 week period of weekly standardized verum acupuncture (intervention).

Participant milestones

Measure	No Acupuncture / Acupuncture 5 weeks of no treatment followed by 5 weeks of standardized verum acupuncture.
No acupuncture (initial 5 weeks) STARTED	14
No acupuncture (initial 5 weeks) COMPLETED	11
No acupuncture (initial 5 weeks) NOT COMPLETED	3
Acupuncture (second 5 weeks) STARTED	11
Acupuncture (second 5 weeks) COMPLETED	10
Acupuncture (second 5 weeks) NOT COMPLETED	1

Reasons for withdrawal

Measure	No Acupuncture / Acupuncture 5 weeks of no treatment followed by 5 weeks of standardized verum acupuncture.
No acupuncture (initial 5 weeks) Withdrawal by Subject	3
Acupuncture (second 5 weeks) Physician Decision	1

Baseline Characteristics

Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

Baseline characteristics by cohort

Measure	No Acupuncture/Acupuncture n=10 Participants No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles.
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=15 Participants
Age, Categorical >=65 years	3 Participants n=15 Participants
Age, Continuous	55.9 years STANDARD_DEVIATION 9.8 • n=15 Participants
Sex: Female, Male Female	5 Participants n=15 Participants
Sex: Female, Male Male	5 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	4 Participants n=15 Participants
Race (NIH/OMB) White	6 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Region of Enrollment United States	10 Participants n=15 Participants

PRIMARY outcome

Timeframe: Baseline, Week 7, Week 13

Left ventricular ejection fraction (LVEF) percentage was measured at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments.

Outcome measures

Measure	Baseline n=10 Participants Measurements at baseline visit.	Pre-Acupuncture n=10 Participants Measurements were taken after 5 full weeks of no treatment. This visit occurred 6-7 weeks after the baseline measurements.	Post-Acupuncture n=10 Participants Measurements were taken after 10 sessions of standardized verum acupuncture administration using 0.18-0.25×30-60-mm stainless steel needles. Acupuncture sessions were scheduled twice a week for 5 weeks. This post-acupuncture visit occurred within 1 week of finishing the acupuncture sessions.
Change in Cardiac Function: LVEF	36.14 LVEF Percentage Standard Deviation 7.23	36.11 LVEF Percentage Standard Deviation 8.97	40.59 LVEF Percentage Standard Deviation 9.28

PRIMARY outcome

Timeframe: Baseline, Week 7, Week 13

Outcome measures

Measure	Baseline n=10 Participants Measurements at baseline visit.	Pre-Acupuncture n=10 Participants Measurements were taken after 5 full weeks of no treatment. This visit occurred 6-7 weeks after the baseline measurements.	Post-Acupuncture n=10 Participants Measurements were taken after 10 sessions of standardized verum acupuncture administration using 0.18-0.25×30-60-mm stainless steel needles. Acupuncture sessions were scheduled twice a week for 5 weeks. This post-acupuncture visit occurred within 1 week of finishing the acupuncture sessions.
Change in 6-Minute Walk Distance	1376.2 Feet Standard Deviation 250.19	1488.0 Feet Standard Deviation 264.82	1515.10 Feet Standard Deviation 268.98

SECONDARY outcome

Timeframe: Baseline, Week 7, Week 13

Patients quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments. Scores reported here are the Quality of Life Scores, which range from 0 to 100. Higher numbers indicate a better quality of life.

Outcome measures

Measure	Baseline n=10 Participants Measurements at baseline visit.	Pre-Acupuncture n=10 Participants Measurements were taken after 5 full weeks of no treatment. This visit occurred 6-7 weeks after the baseline measurements.	Post-Acupuncture n=10 Participants Measurements were taken after 10 sessions of standardized verum acupuncture administration using 0.18-0.25×30-60-mm stainless steel needles. Acupuncture sessions were scheduled twice a week for 5 weeks. This post-acupuncture visit occurred within 1 week of finishing the acupuncture sessions.
Change in Quality of Life (QOL)	65.00 score on a scale Standard Deviation 26.59	67.50 score on a scale Standard Deviation 24.36	69.17 score on a scale Standard Deviation 25.78

Adverse Events

No Acupuncture/Acupuncture

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Acupuncture/Acupuncture n=14 participants at risk No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles.
Cardiac disorders Hospitalization	14.3% 2/14 • Number of events 2 • 10 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. W.H. Wilson Tang, MD

Cleveland Clinic Foundation

Phone: (216) 444-2121

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place