Trial Outcomes & Findings for Study of Renal Denervation in Patients With Heart Failure (NCT NCT01954160)

NCT ID: NCT01954160

Last Updated: 2016-02-02

Results Overview

Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 13 Weeks following Renal Denervation
• Results posted on: 2016-02-02

Participant Flow

5 participants were enrolled. 4 subjects received treatment, 1 subject did not receive treatment due to ineligibility secondary to renal doppler findings.

Participant milestones

Measure	Early Renal Denervation Subjects undergo renal denervation within 2 weeks of baseline visit Symplicity Renal Denervation System	Late Renal Denervation Subjects undergo renal denervation within 2 weeks of Week 13 visit Symplicity Renal Denervation System
Overall Study STARTED	5	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Renal Denervation in Patients With Heart Failure

Baseline characteristics by cohort

Measure	Early Renal Denervation n=4 Participants Subjects undergo renal denervation within 2 weeks of baseline visit Symplicity Renal Denervation System	Late Renal Denervation Subjects undergo renal denervation within 2 weeks of Week 13 visit Symplicity Renal Denervation System	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 participants n=5 Participants	—	4 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 4.4 • n=5 Participants	—	52.5 years STANDARD_DEVIATION 4.4 • n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	3 participants n=5 Participants	—	3 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	—	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected, endpoints not measured

Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Urine volume following furosemide therapy after sodium loading.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Urine albumin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Global longitudinal strain Study terminated early, endpoints not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: LV end systolic dimension (LVESd)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: LV end diastolic dimension (LVEDd)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Left Atrial size

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Heart rate variability indices by Holter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Tissue Doppler indices

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 Weeks following Renal Denervation

Population: Study terminated early, data not collected and therefore endpoints were not measured.

Echo: Left Ventricular End Diastolic Volume

Outcome measures

Outcome data not reported

Adverse Events

Early Renal Denervation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Late Renal Denervation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Early Renal Denervation n=4 participants at risk Subjects undergo renal denervation within 2 weeks of baseline visit Symplicity Renal Denervation System	Late Renal Denervation Subjects undergo renal denervation within 2 weeks of Week 13 visit Symplicity Renal Denervation System
Cardiac disorders Cardiomyopathy	25.0% 1/4 • Number of events 1 • up to one year post randomization	— 0/0 • up to one year post randomization
Metabolism and nutrition disorders Hyperglycemia	25.0% 1/4 • Number of events 1 • up to one year post randomization	— 0/0 • up to one year post randomization

Other adverse events

Measure	Early Renal Denervation n=4 participants at risk Subjects undergo renal denervation within 2 weeks of baseline visit Symplicity Renal Denervation System	Late Renal Denervation Subjects undergo renal denervation within 2 weeks of Week 13 visit Symplicity Renal Denervation System
Musculoskeletal and connective tissue disorders Groin Pain	25.0% 1/4 • Number of events 1 • up to one year post randomization	— 0/0 • up to one year post randomization
General disorders Non Cardiac Chest Pain	25.0% 1/4 • Number of events 1 • up to one year post randomization	— 0/0 • up to one year post randomization

Additional Information

Kathy Moore

Duke Clinical Research Institute

Phone: 919-668-8065

Email: kathy.moore@dm.duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place