Trial · NCT01970176
Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)
NCT01970176, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2020-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2). Trials, record NCT01970176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01970176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)
- NCT number
- NCT01970176
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Cardiomyopathy, Renal Impairment
- Interventions
- Tadalafil, Placebo
- First posted
- 2013-10-25
- Last updated
- 2021-06-11
- Results first posted
- 2020-07-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Urinary Sodium Excretion | Baseline, 12 weeks | Change in total urinary sodium excretion as measured by MEq/min |
| Secondary | Change in Glomerular Filtration Rate (GFR) | Baseline, 12 weeks | Change in total GFR as measured by ml/1.72m2 |
| Secondary | Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion | Baseline, 12 weeks | Change in total urinary cGMP hormone excretion as measured by pmol/min |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Urinary Sodium Excretion | Baseline, 12 weeks | MEq/min | MEDIAN | |
| SECONDARY | Change in Glomerular Filtration Rate (GFR) | Baseline, 12 weeks | ml/1.72m2 | MEDIAN | |
| SECONDARY | Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion | Baseline, 12 weeks | pmol/min | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Urinary Sodium Excretion | Tadalafil | 29.5 | Inter-Quartile Range -4.2 to 77.2 | MEq/min | |
| Change in Urinary Sodium Excretion | Placebo | 25.1 | Inter-Quartile Range 2.9 to 61.3 | MEq/min | |
| Change in Glomerular Filtration Rate (GFR) | Tadalafil | -6.2 | Inter-Quartile Range -30.0 to -1.5 | ml/1.72m2 | |
| Change in Glomerular Filtration Rate (GFR) | Placebo | 4.5 | Inter-Quartile Range -18.5 to 11 | ml/1.72m2 | |
| Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion | Tadalafil | -71.1 | Inter-Quartile Range -266.0 to -41.0 | pmol/min | |
| Change in Urinary Cyclic Guanosine 3',5'-Monophosphate (cGMP) Hormone Excretion | Placebo | 51.6 | Inter-Quartile Range -198.0 to 237.0 | pmol/min |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tadalafil | 14 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Tadalafil | 14 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Tadalafil | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Indigestion | Gastrointestinal disorders | Tadalafil | 2 | 14 | 2 |
| other | Indigestion | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Urinary Tract Infection | Renal and urinary disorders | Tadalafil | 0 | 14 | 0 |
| other | Urinary Tract Infection | Renal and urinary disorders | Placebo | 1 | 6 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Tadalafil | 3 | 14 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Headache | Nervous system disorders | Tadalafil | 1 | 14 | 1 |
| other | Headache | Nervous system disorders | Placebo | 0 | 6 | 0 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Tadalafil | 1 | 14 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 6 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil | 0 | 14 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | Tadalafil | 8 | 14 |
| Total, other adverse events | Placebo | 1 | 6 |
| Total, serious adverse events | Tadalafil | 0 | 14 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35001638 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tadalafil vs Placebo: deaths from any cause | Trial comparisons |
| Tadalafil vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01970176
GET https://conductscience.org/api/trials/v1/NCT01970176/registered