Trial Outcomes & Findings for A Comparison of Hydrochlorothiazide and Metolazone in Combination With Furosemide in Congestive Heart Failure Patients (NCT NCT00690521)
NCT ID: NCT00690521
Last Updated: 2024-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
First Intervention (4 days), Washout (7 days), and Second Intervention (4 days)
Results posted on
2024-10-10
Participant Flow
8 patients enrolled and received drug treatment.
Participant milestones
| Measure |
Arm 1-Furosemide + Hydrochlorothiazide Then Furosemide + Metolazone
A Randomized, double-blind, crossover study designed to compare the efficacy of furosemide in combination with hydrochlorothiazide or metolazone in congestive heart failure patients.
First Intervention- Furosemide and Hydrochlorothiazide (4 days) Washout (7 days) Second Intervention-Furosemide + Metolazone (4 days)
Combined results for both therapies are being reported since it cannot be determined which arm/group was assigned to Hydrochlorothiazide or metolazone
|
Arm-2 Furosemide + Metolazone Then Furosemide + Hydrochlorothiazide
A Randomized, double-blind, crossover study designed to compare the efficacy of furosemide in combination with hydrochlorothiazide or metolazone in congestive heart failure patients.
First Intervention-Furosemide + Metolazone (4 days) Washout (7 days) Second Intervention-Furosemide and Hydrochlorothiazide (4 days)
Combined results for both therapies are being reported since it cannot be determined which arm/group was assigned to Hydrochlorothiazide or metolazone
|
|---|---|---|
|
First Intervention (4 Days)
STARTED
|
4
|
4
|
|
First Intervention (4 Days)
COMPLETED
|
4
|
4
|
|
First Intervention (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
4
|
4
|
|
Washout (7 Days)
COMPLETED
|
4
|
4
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Days)
STARTED
|
4
|
4
|
|
Second Intervention (4 Days)
COMPLETED
|
4
|
4
|
|
Second Intervention (4 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Hydrochlorothiazide and Metolazone in Combination With Furosemide in Congestive Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Arm 1
n=8 Participants
A Randomized, double-blind, crossover study designed to compare the efficacy of furosemide in combination with hydrochlorothiazide or metolazone in congestive heart failure patients.
First Intervention with Furosemide and Hydrochlorothiazide (4 days), Washout (7 days), and Second Intervention with Furosemide + Metolazone(4 days).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First Intervention (4 days), Washout (7 days), and Second Intervention (4 days)Outcome measures
| Measure |
Arm1- Furosemide and Hydrochlorothiazide Then Furosemide + Metolazone
n=4 Participants
A Randomized, double-blind, crossover study designed to compare the efficacy of furosemide in combination with hydrochlorothiazide or metolazone in congestive heart failure patients.
First Intervention-Furosemide and Hydrochlorothiazide (4 days) Washout (7 days) Second Intervention-Furosemide + Metolazone (4 days)
Combined results for both therapies are being reported since it cannot be determined which arm/group was assigned to Hydrochlorothiazide or metolazone
|
Arm2-Furosemide and Metolazone Then Furosemide and Hydrochlorothiazide
n=4 Participants
A Randomized, double-blind, crossover study designed to compare the efficacy of furosemide in combination with hydrochlorothiazide or metolazone in congestive heart failure patients.
First Intervention-Furosemide and Metolazone (4 days) Washout (7 days) Second Intervention-Furosemide and Hydrochlorothiazide (4 days),
Combined results for both therapies are being reported since it cannot be determined which arm/group was assigned to Hydrochlorothiazide or metolazone
|
|---|---|---|
|
Participants With Change in Urinary Output
First Intervention (4 days)
|
4 participants
|
4 participants
|
|
Participants With Change in Urinary Output
Washout (7 days)
|
4 participants
|
4 participants
|
|
Participants With Change in Urinary Output
Second Intervention (4 days)
|
4 participants
|
4 participants
|
Adverse Events
Arm 1-First Intervention-Furosemide + Hydrochlorothiazide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 1-Second Intervention-Furosemide + Metolazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2-First Intervention-Furosemide + Metolazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2-Second Intervention-Furosemide + Hydrochlorothiazide
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place