Trial Outcomes & Findings for Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease (NCT NCT01598740)
NCT ID: NCT01598740
Last Updated: 2013-07-19
Results Overview
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Results posted on
2013-07-19
Participant Flow
The first subject was enrolled on 01 June 2012 and the last subject completed on 06 August 2012. The study was completed at one research center.
Each study period included a 5-day baseline period followed by a 7-day treatment period. The study periods were separated by a 7-day washout period.
Participant milestones
| Measure |
CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)
Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
|
CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)
Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
9
|
9
|
|
Period 1
COMPLETED
|
9
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
8
|
9
|
|
Period 2
COMPLETED
|
7
|
9
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
CLP + Spiro/CLP
n=9 Participants
Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
|
CLP/CLP + Spiro
n=9 Participants
Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.3 years
STANDARD_DEVIATION 7.58 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Weight
|
91.35 kg
STANDARD_DEVIATION 24.20 • n=5 Participants
|
99.54 kg
STANDARD_DEVIATION 27.49 • n=7 Participants
|
95.4 kg
STANDARD_DEVIATION 25.8 • n=5 Participants
|
|
Diet
Low sodium
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Diet
Medium sodium
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diet
High sodium
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Outcome measures
| Measure |
Treatment Group: CLP Alone
n=16 Participants
oral administration
|
Treatment Group: CLP + Spironolactone
n=18 Participants
CLP: oral administration Spironolactone: oral administration
|
|---|---|---|
|
Change in Fecal Sodium Content
|
635.10 mg
Standard Deviation 441.11
|
501.95 mg
Standard Deviation 342.52
|
SECONDARY outcome
Timeframe: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)
Outcome measures
| Measure |
Treatment Group: CLP Alone
n=16 Participants
oral administration
|
Treatment Group: CLP + Spironolactone
n=18 Participants
CLP: oral administration Spironolactone: oral administration
|
|---|---|---|
|
Change in Fecal Weight
|
144.7 grams
Standard Deviation 86.50
|
119.0 grams
Standard Deviation 106.98
|
Adverse Events
Treatment Group: CLP Alone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Group: CLP + Spironolactone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group: CLP Alone
n=16 participants at risk
oral administration
|
Treatment Group: CLP + Spironolactone
n=18 participants at risk
CLP: oral administration Spironolactone: oral administration
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
2/16
|
11.1%
2/18
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16
|
0.00%
0/18
|
|
General disorders
Asthenia
|
0.00%
0/16
|
5.6%
1/18
|
|
General disorders
Fatigue
|
6.2%
1/16
|
0.00%
0/18
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/16
|
11.1%
2/18
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16
|
11.1%
2/18
|
|
Nervous system disorders
Headache
|
6.2%
1/16
|
5.6%
1/18
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
6.2%
1/16
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/16
|
5.6%
1/18
|
|
Vascular disorders
Hypotenstion
|
0.00%
0/16
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER