Mechanisms of Diuretic Resistance in Heart Failure, Aim 1

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bumetanide Injection — DRUG
  Participants in balance will present to the study site Day 0 and receive their first randomized dose of bumetanide (1.25mg, 2.5mg, 5mg, or 10mg) and undergo the bio-specimen collection protocol. They will return every 3 days, allowing 2 full days washout, to receive the other doses in random sequence.

Study Details

This study will employ a randomized order, double-blind, repeated measures dose ranging design. This design was chosen in order to generate multiple within-subject serial loop diuretic dose response exposures. The overall study schema will include 75 heart failure (HF) patients.

Key Dates

Start date

Jun 1, 2022

Status verified

May 2026

Primary completion

May 1, 2027

Completion

May 1, 2027

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Arms

• Active Comparator: Bumetanide 10 mg
  Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg
• Active Comparator: Bumetanide 5 mg
  5 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg
• Active Comparator: Bumetanide 2.5 mg
  2.5 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg
• Active Comparator: Bumetanide 1.25 mg
  1.25 mg Randomized to doses 10 mg, 5 mg, 2.5 mg, 1.25 mg

Primary Outcome Measure

Change in fractional excretion of lithium(FELi) pre-diuretic to 1-hour post IV bumetanide infusion [ Time Frame: Baseline and 1 hour post bumetanide infusion. ]

Central Contacts

• Veena Rao
  2037373571
  [email protected]

Locations (1)

Find similar trials in New Haven, CT

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