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1 for Congestive Heart Failure

Phase 4
Waitlist Available
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Diagnosis of chronic congestive heart failure with an ejection fraction ≤45%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days
Awards & highlights

Study Summary

The purpose of this research study is to compare the effectiveness of hydrochlorothiazide or metolazone in combination with furosemide. Patients with heart failure suffer from swelling because of too much fluid in the body. Furosemide, hydrochlorothiazide, and metolazone are all water pills used to treat the swelling. For most patients, taking furosemide alone is successful. However, sometimes patients need to add another water pill. Doctors usually add either metolazone or hydrochlorothiazide. It is not clear which water pill is better when added to furosemide. The purpose of this study is to determine which water pill when added to furosemide is the best at reducing excess fluid in the body.

Eligible Conditions
  • Congestive Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint will be change in urinary output.
Secondary outcome measures
Secondary endpoints will be changes in weight, neurohormones (angiotensin II, catecholamines, brain natriuretic peptide, aldosterone), and electrocardiographic parameters of ventricular instability.

Trial Design

2Treatment groups
Active Control
Group I: 1Active Control1 Intervention
Patients will be randomized to receive either metolazone or HCTZ in a randomized, double-blind, placebo controlled crossover trial. The patients will receive the alternative medication if The specific dose of hydrochlorothiazide will be determined by the individual's creatinine clearance. A creatinine clearance of 30-50 mL/min will indicate a dose of 50 mg per day. A creatinine clearance of > 50 mL/min will indicate a dose of 25 mg per day.5 If metolazone is added to their regimen, the specific dose will be determined using the equivalence ratio of 5 mg metolazone to 50 mg hydrochlorothiazide.
Group II: 2Active Control1 Intervention
Patients will be randomized to receive either metolazone or HCTZ in a randomized, double-blind, placebo controlled crossover trial. The patients will receive the alternative medication if The specific dose of hydrochlorothiazide will be determined by the individual's creatinine clearance. A creatinine clearance of 30-50 mL/min will indicate a dose of 50 mg per day. A creatinine clearance of > 50 mL/min will indicate a dose of 25 mg per day.5 If metolazone is added to their regimen, the specific dose will be determined using the equivalence ratio of 5 mg metolazone to 50 mg hydrochlorothiazide.

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
371 Previous Clinical Trials
3,529,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025