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Heart Failure Reversal Treatment for Chronic heart failure patients.

A Multi center, randomized, open label clinical trial of efficacy of HFRT regimen as an add-on therapy to conventional treatment versus conventional treatment alone for chronic heart failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005384
Enrollment
70
Registered
2015-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I509- Heart failure, unspecified

Interventions

Intervention1: Arm A: HFRT is Heart Failure Reversal Treatment.: HFRT 12 sittings to be given in a period of 6 weeks. Total Duration of Each HFRT sitting is 75 to 80 minutes, Which Includes a) Snehan

Sponsors

Dr Rohit Sane as a Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: To be eligible for the study, patients must meet the following criteria: 1. Provide written informed consent. 2. Male or female patients between 25 to 65 years of age with clinical diagnosis of Chronic Heart Failure (CHF). 3. History of CHF irrespective of angioplasty and coronary artery bypass graft (CABG) on standard Treatment. 4. Stress test MET value between 3 to 7. 5. Ejection fraction between 30%-65% 6. 2D Echo done within 6months

Exclusion criteria

Exclusion criteria: 1.Female patients who are pregnant or lactating or planning to become pregnant during the study period. 2. Acute Heart Failure. 3. Patients who had acute decompensated heart failure attack in last 3 months. 4. Patients who are not on stable dose of standard treatment of chronic heart failure since last 3 months and need upward dose titration will be excluded. 5.Irritable bowel syndrome. 6.Clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles). 7.Hemorrhoids (2nd or 3rd degree). 8.Known case of Asthma or COPD. 9.Known case of cancer. 10.Physical disability in any form leading to immobilization. 11.Uncontrolled hypertension (SBP more than 150 mm of Hg and DBP more than 90 mm of Hg). 12.Anemia (Hemoglobin less than 10 gm/dL). 13.Uncontrolled Blood sugar level (fasting below 60 mg/dL and PLBS above 250 mg/dL). 14 Abnormal thyroid function test. 15 Patients with hepatic or renal insufficiency. 16 Participation in another study within 30 days. 17 Suspected inability or unwillingness to comply with the study procedures. 18.Suspected hypersensitivity to study medication.

Design outcomes

Primary

MeasureTime frame
â?¢Mean change from baseline in MET score â?¢Mean change from baseline in VO2max Timepoint: â?¢Mean change from baseline in MET score at the end of six weeks. â?¢Mean change from baseline in VO2max at the end of six weeks.

Secondary

MeasureTime frame
â?¢Mean change from baseline in quality of life â?¢Mean change from baseline in ejection fraction â?¢Mean change from baseline in time for ischemia â?¢Mean change from baseline in double pressure product â?¢Mean change from baseline in heart rate recovery Timepoint: â?¢Improvement in quality of life assessed by QOL Questionnaire â?¢Improvement in ejection fraction assessed by using Two-Dimensional Echocardiogram (2D Echo) â?¢Improvement in time for ischemia assessed by Stress test (ST in second) â?¢Improvement in double pressure product assessed by blood pressure monitoring â?¢Improvement in heart rate recovery assessed by heart rate monitoring

Countries

India

Contacts

Public ContactDr Rohit Madhav Sane

Vaidya Sane Ayurved Lab PVT LTD (

drrahulmandole@gmail.com02241235315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026