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Nocturnal HypertensionPhase 4NCT03050229

SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)

A Phase 4 study testing Empagliflozin in people with Nocturnal Hypertension and T2DM (Type 2 Diabetes Mellitus), run by Jichi Medical University at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
12 sitesJapan
Study dates
Jan 2017to Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet the following criteria at the start of treatment are eligible for the study:
  • Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
  • Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
  • HbA1c>=6.0%, <10%
  • Seated office SBP 130-159mmHg or DBP 80-99mmHg
  • Nocturnal hypertension (SBP>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
  • Age>=20

Who cannot join

  • Patients who meet any of the following criteria are not eligible for the study:
  • History of hypersensitivity to empagliflozin
  • Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
  • Treated with insulin or SU
  • With renal dysfunction (eGFR<45mL/min/1.73m2)
  • With liver dysfunction (AST or ALT is 3 times higher than reference value)
Show all 14Show fewer
  • Hypotension (systolic blood pressure < 90 mmHg)
  • With pituitary gland dysfunction or adrenal gland dysfunction
  • Heart failure patients whose NYHA class is IV
  • Deemed ineligible for the study due to another reason by investigator
  • History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
  • History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
  • Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
  • Patients received SGLT2 inhibitor within 8 weeks before enrollment

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Fukuoka University Chikushi Hospital

    Fukuoka

  • Kotake Hospital

    Fukuoka

  • Onga Hospital

    Fukuoka

  • Ishiguro Clinic

    Gifu

  • Higashiagatsuma-machi National Health Insurance Clinic

    Gunma

  • Katsuya Iin

    Hyōgo

  • Minamisanriku Hospital

    Miyagi

  • Shibuya Clinic

    Saitama

  • International University of Health and Welfare Hospital

    Tochigi

  • Jichi Medical University hospital

    Tochigi

  • Utsunomiya higashi hospital

    Tochigi

  • Kato Clinic

    Tokyo

Other trials in Japan

About this study

To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

Read the detailed description

The study consists of a 8-week run-in period and a 12-week treatment period.

Being tested
Empagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Also called Jardiance

    Empagliflozin 10mg/day once daily before or after breakfast

  • PlaceboDrug

    Placebo once daily before or after breakfast

Study groups in NCT03050229
Study groupRoleWhat they receive
EmpagliflozinExperimentalEmpagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Receives: Drug: Empagliflozin
PlaceboPlacebo comparatorPlacebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of nocturnal blood pressure measured by ABPM

    Measured: 12 weeks

Secondary outcomes (22)

  1. Reduction of Blood pressure measured by ABPM -24h Blood Pressure

    Measured: 12 weeks

  2. Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure

    Measured: 12 weeks

  3. Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure

    Measured: 12 weeks

  4. Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability

    Measured: 12 weeks

  5. Reduction of Metabolism-related factors -HbA1c

    Measured: 12 weeks

  6. Reduction of Metabolism-related factors -body weight

    Measured: 12 weeks

  7. Reduction of Metabolism-related factors -BMI

    Measured: 12 weeks

  8. Reduction of Metabolism-related factors -lipids

    Measured: 12 weeks

  9. Reduction of Metabolism-related factors -uric acid

    Measured: 12 weeks

  10. Reduction of Metabolism-related factors -HOMA-R

    Measured: 12 weeks

  11. Reduction of Metabolism-related factors -HOMA-beta

    Measured: 12 weeks

  12. Change in Sleep efficacy -Sleep scale (Athens insomnia scale)

    Measured: 12 weeks

  13. Change in Sleep efficacy -Frequency of nocturnal awakening

    Measured: 12 weeks

  14. Change in Sleep efficacy -Frequency of nocturia

    Measured: 12 weeks

  15. Changes in the measures of circulating volume -Plasma NT-proBNP

    Measured: 12 weeks

  16. Changes in the measures of circulating volume -ANP

    Measured: 12 weeks

  17. Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio

    Measured: 12 weeks

  18. Changes in the measures of organ damage -Urinary Na/K

    Measured: 12 weeks

  19. Changes in the measures of organ damage -eGFR

    Measured: 12 weeks

  20. Changes in the measures of organ damage -cystatinC

    Measured: 12 weeks

  21. The correlation between blood pressure and blood glucose control

    Measured: 12 weeks

  22. The correlation between blood pressure and body weight

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study startJan 2017
  3. Primary completionOct 2017
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050229
Sponsor's protocol ID
1245-131
Status last verified
Mar 2018
First submitted
26 Dec 2016
Last updated
27 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kario K, Okada K, Kato M, Nishizawa M, Yoshida T, Asano T, Uchiyama K, Niijima Y, Katsuya T, Urata H, Osuga JI, Fujiwara T, Yamazaki S, Tomitani N, Kanegae H. Twenty-Four-Hour Blood Pressure-Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension: Results From the Randomized, Placebo-Controlled SACRA Study. Circulation. 2019 Apr 30;139(18):2089-2097. doi: 10.1161/CIRCULATIONAHA.118.037076. Epub 2018 Nov 29.

    PubMed 30586745

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin in people with Nocturnal Hypertension and T2DM (Type 2 Diabetes Mellitus), run by Jichi Medical University at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of nocturnal blood pressure measured by ABPM (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050229, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.

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